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U.S. Department of Health and Human Services

Class 2 Device Recall lnvatec SpA brand Diver C.E

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 Class 2 Recall
lnvatec SpA brand Diver C.E
see related information
Date Posted June 07, 2013
Recall Status1 Terminated on June 10, 2013
Recall Number Z-1517-2013
Recall Event ID 65289
Premarket Notification
510(K) Numbers
K050276  K051917 
Product Classification Catheter, Embolectomy - Product Code DXE
Product lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Code Information Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801
Recalling Firm/
Manufacturer
Invatec Llc
3101 Emrick Blvd
Bethlehem, Pennsylvania 18020-8037
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Jonathan Morris
707-566-1143
Manufacturer Reason
for Recall
Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Invatec sent an Urgent - Device Field Action letter dated March 4, 2009, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were required to return a confirmation form, acknowledging the action taken, and identifying affected units in their inventory for return of the product for replacement. The firm indicated that this recall was fully executed in 2009, and this 806 captures the events that took place at that time. For questions regarding this recall call 707-566-1143.
Quantity in Commerce 177 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXE and Original Applicant = INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
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